Tests venetoclax with chemotherapy in newly diagnosed acute myeloid leukemia
Tests venetoclax with chemotherapy in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
Key facts
- Where
- Nanjing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 60 with newly diagnosed acute myeloid leukemia (AML) who have not been treated before.
- Age
- 18 to 60 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed primary AML, diagnosed by the 2022 WHO classification. Performance status ECOG 0-2.
- Earlier treatment
- No earlier venetoclax. No strong or moderate CYP3A inducer or inhibitor drugs in the 7 days before starting.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL)
- Relapsed or refractory AML
- Known leukemia in the central nervous system
- Known HIV infection
- Uncontrolled infection, or positive hepatitis B or C (non-active carriers are not excluded)
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06232694, who can take part
Where in China
- The First Affiliated Hospital with Nanjing Medical UniversityNanjing, ChinaContact: Ming Hong, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT06232694
- Record updated
- 31 January 2024
- Original description
This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML).Read full original descriptionShow less
Clinical Study Protocol of Idarubicin, Cytarabine, and Venetoclax -Induced Remission Followed by Consolidation Therapy With Medium-dose Cytarabine Combined With Venetoclax in Newly Diagnosed Adult Acute Myeloid Leukemia
This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML).
This study includes the induction and consolidation phases of AML treatment.
Inclusion: Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification; Age between 18 and 60 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2); Cardiac ultrasound LVEF ≥ 45%; Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample); Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN*; Alanine aminotransferase (ALT) ≤ 2.5 × ULN*; Total bilirubin ≤ 1.5 × ULN* (*unless considered due to leukemia infiltration); Signed informed consent form.
Exclusion: Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded; Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment; Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs; Participants with New York Heart Association (NYHA) functional classification > Grade 2. Grade 2 is defined as patients having cardiac disease with no symptoms at rest but experiencing fatigue, palpitations, dyspnea, or angina with ordinary physical activity; Participants with chronic respiratory disease requiring continuous oxygen therapy; Patients unable to take oral medications or with malabsorption syndrome; Presence of uncontrolled systemic infection (viral, bacterial, or fungal); Acute promyelocytic leukemia (APL); Relapsed/refractory AML patients; AML patients with known involvement of the central nervous system (CNS).